title: RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID-TIA): study protocol for a pilot randomised controlled trial.
abstract: BACKGROUND
  People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist--that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist?
  
  
  METHODS
  This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final TIA clinic diagnosis as the reference standard.
  
  
  CONCLUSIONS
  This pilot study will be used to estimate key parameters that are needed to design the main study and to estimate the accuracy of primary care diagnosis of TIA. The planned follow-on trial will have important implications for the initial management of people with suspected TIA.
  
  
  BACKGROUND
  ISRCTN62019087.
authors.affiliation: General Practice and Primary Care Research Unit, Institute of Public Health, University of Cambridge, Forvie Site, Robinson Way, Cambridge CB2 0SR, UK.
authors.forename: Duncan
authors.initials: D
authors.lastname: Edwards
authors.forename: Kate
authors.initials: K
authors.lastname: Fletcher
authors.forename: Rachel
authors.initials: R
authors.lastname: Deller
authors.forename: Richard
authors.initials: R
authors.lastname: McManus
authors.forename: Daniel
authors.initials: D
authors.lastname: Lasserson
authors.forename: Matthew
authors.initials: M
authors.lastname: Giles
authors.forename: Don
authors.initials: D
authors.lastname: Sims
authors.forename: John
authors.initials: J
authors.lastname: Norrie
authors.forename: Graham
authors.initials: G
authors.lastname: McGuire
authors.forename: Simon
authors.initials: S
authors.lastname: Cohn
authors.forename: Fiona
authors.initials: F
authors.lastname: Whittle
authors.forename: Vikki
authors.initials: V
authors.lastname: Hobbs
authors.forename: Christopher
authors.initials: C
authors.lastname: Weir
authors.forename: Jonathan
authors.initials: J
authors.lastname: Mant
mesh_terms: D000959:Antihypertensive Agents / Q000008:administration & dosage; D001241:Aspirin / Q000008:administration & dosage; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002985:Clinical Protocols; D004176:Dipyridamole / Q000008:administration & dosage; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004636:Emergency Service, Hospital; D004739:England; D005240:Feasibility Studies; D058006:General Practice; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage; D002546:Ischemic Attack, Transient / Q000175:diagnosis / Q000188:drug therapy*; D010865:Pilot Projects; D011320:Primary Health Care; D012017:Referral and Consultation; D012107:Research Design; D055502:Secondary Prevention / Q000379:methods*; D019821:Simvastatin / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D002317:Cardiovascular Agents; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D004176:Dipyridamole; D019821:Simvastatin; D001241:Aspirin